Echo-guided Transverse Abdominal Plane Block (TAP) in Anterior Lumbar Arthrodesis (ALIF)

NCT06002217 | Recruiting

• 1 other identifier: 2022-A00970-43
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this interventional study is to is to compare the effect of a tap block versus a placebo in patients undergoing anterior lumbar spine surgery. The main question it aims to answer : • whether tap block can reduce the need for postoperative pain medication Participants will be randomized into two groups and all postoperative pain medication will be recorded over 3 days. Researchers will compare tap block vs placebo to see if it reduces postoperative pain.

Conditions

Fusion of Spine, Lumbar Region

Outcome Measures

Primary Outcomes (1)

• Analgesic consumption

  The use of analgesics (oral or venous) during the during the 72 hours following surgery

  72hours

Secondary Outcomes (1)

• Pain assessment will be reported for 72 hours after surgery measured on a Visual analogue scale between 0 and 10

  72hours

Study Arms (2)

TAP Block

ACTIVE COMPARATOR

Drug: Levobupivacaine

saline solution

PLACEBO COMPARATOR

Other: Placebo Tap block

Interventions

Levobupivacaine DRUG

Patients in the tap block arm will receive an injection of levobupivacaine 2.5mg/ml

TAP Block

Placebo Tap block OTHER

Patients in the placebo arm will receive an injection of salin solution 2.5mg/ml , in the same way as tap block

saline solution

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient affiliated or entitled to a social security plan.
• Patient who has been informed about the study and has co-signed a consent form with the investigator. consent to participate in the study.
• Patients over 18 years of age scheduled for abdominal disc surgery on one or two levels.
• Patient with ASA criteria 1, 2 and 3.

You may not qualify if:

• Patients with intolerance or contraindication to paracetamol, anti-inflammatory or morphine.
• Patients allergic to local anesthetics.
• Pregnant or breast-feeding patient.
• patient undergoing cancer or trauma surgery trauma.
• Patient participating in another interventional study.
• Patient with a history of lumbar arthrodesis.
• Patient refusing to sign consent form.
• Patient unable to give informed consent.
• Patient under court protection, guardianship or trusteeship.
• Patient not available for study follow-up.

Sponsors & Collaborators

• Clinique Saint Jean, France: lead

Study Sites (1)

Clinique St jean sud de france

Montpellier, 34430, France

RECRUITING

MeSH Terms

Interventions

Levobupivacaine

Intervention Hierarchy (Ancestors)

Bupivacaine; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: August 9, 2023
• First Posted: August 21, 2023
• Study Start: February 5, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: January 6, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)